Randomized, Controlled, Double Blind, to Evaluate the Postpartum Analgesia With Epidural Morphine: Analgesic Effect of Two Different Doses Compared to Placebo (IMI)

May 10, 2021 updated by: Universidad Nacional de Colombia
This study aims to assess the analgesic effect of two different doses of epidural morphine for postpartum analgesia management. Previous studies have shown that conventional management of postpartum pain (acetaminophen, NSAIDs) is insufficient, in the investigators country is wasted using the epidural catheter is placed as part of the analgesic management of pregnant women in labor.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The intervention is the epidural administration of morphine in two doses 2mg and 3mg different vs placebo 1 hour after delivery care maternal vaginal in patients who received epidural analgesia in labor, in order to evaluate the analgesic effectiveness post operations of the different doses vs placebo.

In the analysis to determine whether the proposed levels are effective for postpartum pain control was carried out by determining the differences between experimental groups and control group, and in examining the statistical significance of the differences found by applying the relevant tests according to whether the variable is normally distributed or not.

The main variables analyzed were:

rating of pain intensity, number of analgesics required required dose of analgesics used to achieve adequate control pain, number of pain episodes and percentage of patients free of these episodes, duration of action of the dose used.

Similar analysis was determined by the incidence of side effects, in particular those described in classic form, pruritus, nausea and vomiting, urinary retention, and respiratory depression

Were classified into three groups: two experimental and one control group.

Experimental Group 1 will receive 10 ml of solution prepared as follows:

2 mg of morphine diluted in 0.9% normal saline

Experimental Group 2 will receive 10 ml of solution prepared as follows:

3 mg of morphine diluted in 0.9% normal saline

The control group will receive 10 ml of normal saline (SSN).

The randomization codes were kept in a sealed envelope so individual, and the envelopes were guarded and uncovered after a eligible to participate in the study agreed to be included and signed the informed consent.

Anesthesia Technique for the Study

In ASA II patients in labor who were initiates of labor analgesia with epidural catheter has been placed ideally at the level of L3-L4 (Tuohy catheter conventional number 18, introduced by loss of resistance technique) .

The patients were started a conventional dose of analgesia with bupivacaine 0.5% + fentanyl 100mcg 10mg 10cc carried in a bolus. Administered bupivacaine + 10 mg bolus of fentanyl 100mcg as needed to strengthen the epidural analgesia

or Infusion Bupivacaine 0.125% + Fentanyl 100mcg%

In a 10cc bolus then 8-16CC hours

In patients 1 hour after having her expulsive morphine were previously applied in laboratory and packaged in disregard of the anesthesiologist applied morphine 2mg - 3mg or saline placebo.

The dose will be applied 1 hour after birth in search of having no residual analgesic effect of local anesthetic and opioid epidural analgesia initially applied.

All patients will be managed with conventional analgesia performed in the institution acetaminophen 1 g every 6 hours VO

If additional merit the first choice analgesic diclofenac 75mg IM is, if no answer will apply a dose of 100mg tramadol or morphine IV in titrated only if warranted more analgesia.

For all patients will have availability of naloxone in case of respiratory depression.

Patients will be observed for 24 hours with monitoring the consumption of other analgesics, pain visual analog scale, which is evaluated at the time of the application of morphine, 2h, 4h, 6h 12h and 24h after application of morphine. Also evaluated variables such as development of pruritus, nausea, vomiting, urinary retention and assessment of respiratory rate.

Study Type

Interventional

Enrollment (Actual)

114

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
      • Bogota, Colombia
        • Universidad Nacional; Maternal and Child Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients postpartum vaginal conventional analgesia management of your labor
  • ASA II
  • Do not include patients with history of allergy to morphine.
  • Patients who agreed to be included in the study but did not sign informed consent.

Exclusion Criteria:

  • Submit a complication that makes it difficult postoperative pain assessment or adverse effects after surgery.
  • Patients who, after having been included, express their desire to be excluded. Patients with incomplete follow-up.id
  • Did not include patients who have absolute contraindications for epidural anesthesia, or could not provide informed consent, as in the following cases: local infection at the site of administration, systemic infection, bleeding disorders, disease of the spine , mental patients, drug history, sleep apnea, history of headache post-puncture headache or frequent any kind.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Patients en treatment whit placebo, salIne solution in peridural cateter
Drug: saline solution
4 cc of saline solution in epidural cateter in postpartum
Other Names:
  • Random code numbers
Active Comparator: Morphine
Epidural Catheter morphine 2mg
Drug: Morphine
morphine 3 mg
Other Names:
  • Random code numbers
Drug: Morphine
morphine 2 mg for epidural cateter in postpartum
Other Names:
  • Random code numbers
Active Comparator: morphine
Epidurla cateter morphine 3 mg
Drug: Morphine
morphine 3 mg
Other Names:
  • Random code numbers
Drug: Morphine
morphine 2 mg for epidural cateter in postpartum
Other Names:
  • Random code numbers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The analgesic efficacy: : pain intensity rating
Time Frame: The first 24 hours after administration
The analgesic efficacy at controlling pain after delivery
The first 24 hours after administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the incidence of side effects
Time Frame: the first 24 hours after administration
In particular those described in the literature, such as pruritus, nausea, vomiting, urinary retention and respiratory depression
the first 24 hours after administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Nacional de Colombia

Investigators

  • Study Chair: Dario J Perea, Medical, Universidad Nacional de Colombia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

October 13, 2011

First Submitted That Met QC Criteria

May 10, 2021

First Posted (Actual)

May 14, 2021

Study Record Updates

Last Update Posted (Actual)

May 14, 2021

Last Update Submitted That Met QC Criteria

May 10, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7245408

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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